Package leaflet: Information for the patient

Piracetam Espefa, 1200 mg, coated tablets
Piracetam
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents

What Piracetam Espefa is and what it is used for
Important information before taking Piracetam Espefa
How to take Piracetam Espefa
Possible side effects
How to store Piracetam Espefa
Contents of the pack and other information

1. What Piracetam Espefa is and what it is used for

Piracetam Espefa is a medicine belonging to the group of nootropic drugs. This medicine reduces blood viscosity and increases blood flow through cerebral vessels without dilating them. It also enhances oxygen utilization and glucose consumption in ischemic brain tissue.
Indications

Treatment of cortical myoclonus (brief, sudden, "lightning-like" muscle jerks affecting one or more limbs or the trunk);
Treatment of dyslexic disorders in children, used concomitantly with speech therapy;
Treatment of vertigo.

2. Information before taking Piracetam Espefa

When not to take Piracetam Espefa:

if the patient is allergic to piracetam, other pyrrolidone derivatives, or to any of the other ingredients of this medicine (listed in section 6);
if the patient has end-stage renal failure;
if the patient has intracranial bleeding. The most common symptoms are severe headache, partial paralysis (e.g. facial muscles with speech disturbances) and vomiting;
if the patient has Huntington's chorea (characterized by involuntary movements, irritability, depression, and memory disturbances).

Warnings and precautions
Before starting treatment with Piracetam Espefa, discuss the following with a doctor:

if the patient has impaired kidney function (renal failure);
if the patient is elderly (over 65 years of age);
if the patient has blood coagulation disorders;
if the patient has severe hemorrhage.

Particular caution is required in patients:

at risk of bleeding (e.g. due to peptic ulcer disease of the stomach and intestines);
with disorders of hemostasis (the mechanism preventing blood leakage from blood vessels, both under normal conditions and after vascular injury);
with a history of hemorrhagic stroke;
taking anticoagulant medicines or medicines inhibiting platelet aggregation (clumping of platelets) (see section: "Piracetam Espefa and other medicines");
who are scheduled for major surgical procedures, including dental surgery.

Do not abruptly discontinue treatment with piracetam in patients being treated for myoclonus, to avoid recurrence of myoclonus or generalized seizures.
Piracetam Espefa and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient intends to take.
The patient should inform the doctor if taking any of the following medicines:

thyroid hormones (e.g. thyroxine – used in the treatment of hypothyroidism) – due to the risk of irritability, insomnia, and confusion (disturbance in thought process, disorientation);
anticoagulant medicines, e.g. acenocoumarol (medicines reducing the risk of blood clot formation).

The likelihood of piracetam causing disturbances in the metabolism of other medicines is low.
Taking Piracetam Espefa with food, drink and alcohol
This medicine may be taken during meals or between meals.
Alcohol consumption is not recommended during treatment with this medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy due to insufficient data on the use of piracetam in pregnant women.
This medicine should not be used during breastfeeding, as it passes into human milk.
Driving and operating machinery
This medicine may affect the ability to drive and operate machinery. If drowsiness or dizziness occurs, the patient should not drive or operate machinery.
Piracetam Espefa contains carmoisine (azo dye)
This medicine may cause allergic reactions.
Piracetam Espefa contains sodium
The tablet contains less than 1 mmol (23 mg) of sodium, meaning the medicine is considered "sodium-free".
However, the maximum daily dose (24 g of piracetam) contains approximately 1.7 to 3 mmol (or 40 to 70 mg) of sodium (the maximum daily sodium intake recommended for adults by WHO = 2 g).

3. How to take Piracetam Espefa

Piracetam Espefa must always be taken as directed by the physician. If in doubt,
consult a doctor or pharmacist.
To allow planning and administration of an appropriate dosing regimen, Piracetam ESPEFA
is also available in a 800 mg strength.
1000 mg converted to grams is: 1 g.
One 1200 mg coated tablet converted to grams is: 1.2 g.
Recommended dose
Treatment of cortical myoclonus
The initial dose is 2 tablets three times daily (7.2 g of drug per day).
If necessary, the physician may recommend gradually increasing the dose by 4.8 g of
drug every 3 or 4 days. The maximum daily dose is 20 tablets (24 g of drug),
administered in divided doses, i.e. 2 or 3 times daily.
In combination therapy with other antiepileptic (antimyoclonic) drugs, the doses of other
medications should be maintained at their recommended therapeutic levels. If the patient's condition
improves, the physician may reduce the doses of other drugs (when possible).
In patients with myoclonus, every 6 months the physician may attempt to reduce or discontinue
the drug. To achieve this, the dose should be reduced by 1.2 g of drug every 2 days to prevent sudden
recurrence of the disease.
Treatment of dyslexic disorders in children in combination with speech therapy
In combination with speech therapy in children and adolescents aged 8 to 13 years:
3.2 g of drug per day in 2 divided doses.
Treatment of vertigo
2.4 g of drug per day in 3 divided doses. Treatment lasts 8 weeks.
Use of Piracetam Espefa in patients with impaired renal function
The physician may reduce the dose of piracetam in patients with impaired renal function.
Use of Piracetam Espefa in elderly patients
In elderly patients undergoing long-term treatment with piracetam, the physician will individually adjust
the dose after assessing renal function.
Overdose of Piracetam Espefa
In case of overdose, seek immediate medical advice.
Missed dose of Piracetam Espefa
Continue taking the medication as prescribed without increasing the next dose.
Do not take a double dose to make up for a missed dose.
Discontinuation of Piracetam Espefa
Do not stop taking the medication without consulting your doctor.
Discontinuation of piracetam treatment in patients with myoclonus increases the risk of epileptic seizures.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if any of the following symptoms occur:
skin redness, swelling, urticaria, breathing difficulties, laryngeal swelling causing breathing problems. These
are symptoms of an allergic reaction.
The following adverse reactions may occur
Common (occur in 1 to 10 out of 100 people):

nervousness;
weight gain;
increased motor activity (hyperkinesia).

Uncommon (occur in 1 to 10 out of 1,000 people):

general physical weakness (asthenia);
depression;
drowsiness.

Frequency not known (cannot be estimated based on available data):

bleeding disorders;
allergic reactions;
irritability, restlessness, anxiety;
confusion (disorders in thought processes, disturbances in orientation to time, place, situation or self);
hallucinations (perception of non-existent objects or people);
dizziness, headache;
abdominal or epigastric pain;
diarrhoea, nausea, vomiting;
angioedema (sudden swelling of the face, limbs or joints without itching or pain);
skin inflammation;
itching, urticaria (bright pink, itchy skin blisters);
disturbances in body motor coordination (ataxia), difficulty maintaining balance, unsteady gait;
worsening of epilepsy symptoms;
insomnia.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02–222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Piracetam Espefa

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Piracetam Espefa contains

The active substance is piracetam. One coated tablet contains 1200 mg of piracetam.
Other ingredients are: core: microcrystalline cellulose, anhydrous colloidal silicon dioxide, sodium croscarmellose, talc, magnesium stearate; coating: hypromellose, stearic acid, talc, titanium dioxide (E 171), carmoisine, lake (E 122).

What Piracetam Espefa looks like and contents of the pack
Piracetam Espefa is a pink, film-coated, oblong tablet.
The pack contains 60 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Chemical and Pharmaceutical Cooperative "ESPEFA"
J. Lea 208
30-133 Kraków
Poland
Tel.: +48 12 639 27 27
Fax: +48 12 639 96 45
Information for blind and partially sighted people: 800-007-777